Objective To evaluate the efficacy and safety of memantine in the treatment of Alzheimer’s disease (AD). Methods The randomized controlled trials (RCTs) about memantine vs. donepezil for patients with AD from January 1989 to July 2011 were searched in CBM, CNKI, WanFang Data, MEDLINE, OVID, EMbase and The Cochrane Library. Two reviewers independently screened the literatures, extracted the data, and evaluated the methodological quality. Then meta-analyses were conducted by using RevMan 5.0 software. Results The total 12 RCTs were included. Among the 2 716 patients involved, 1 459 were in the memantine group, while the other 1 302 were in the donepezil group. The results of meta-analyses showed that the efficacy of the memantine group was superior to that of the donepezil group in MMSE (MD=0.53, 95%CI 0.21 to 0.85, P=0.001), CIBIC-Plus (MD= –0.19, 95%CI –0.31 to –0.07, P=0.002), NPI (MD= –2.9, 95%CI –4.57 to –1.22, P=0.000 7) and SIB (MD=3.12, 95%CI 0.57 to 5.67, P=0.02), with significant differences; but the efficacy of the two groups was similar in ADCS-ADL19 (MD=0.29, 95%CI –0.03 to 0.60, P=0.07). There was no significant difference between the two groups in incidence of side effects (RR=1.14, 95%CI 0.94 to 1.38, P=0.17), but the tolerability of the memantine group was much better (RR=0.78, 95%CI 0.63 to 0.97, P=0.03). Conclusion Based on the current studies, memantine is superior to donepezil in treating Alzheimer’s disease (AD) at present. Although the side effects are similar to donepezil, memantine has much better intolerability and is considered to be safe and effective. For the quality restrictions and possible publication bias of the included studies, more double blind RCTs with high quality are required to further assess the effects.
Objective To evaluate the effectiveness and safety of donepezil in the treatment of senile vascular dementia. Methods The databases such as the Chinese Journal Full-text Database, Chinese Biomedical Literature Database, Chinese Scientific Journals Full-text Database, Chinese Biomedicine Database, PubMed and The Cochrane Library were searched by computer, and the related journals and conference proceedings were also manually searched to include randomized controlled trials (RCTs) on donepezil in the treatment of senile vascular dementia. Studies were screened according to the inclusion and exclusion criteria, data were extracted, the methodological quality of the included studies was assessed according to Jadad score criterion, and meta-analyses were performed by using RevMan 5.0 software. Results Among 25 studies (3586 patients) included, eight described the randomization methods, and three described the double blind methods. The results of meta-analyses showed, compared with the placebo group, donepezil was superior in improving vascular dementia patients’ cognition level (three studies, MD= –1.25, 95%CI –1.61 to –0.88, Plt;0.000 01), intellectual spirit level (two studies, MD=0.66, 95%CI 0.35 to 0.97, Plt;0.000 1), dementia level (three studies, MD= –0.74, 95%CI –1.16 to –0.31, P=0.004), and viability level (two studies, MD= –0.74, 95%CI –1.16 to –0.31, P=0.000 6). In improving the intellectual spirit level, donepezil was superior to piracetam (seven studies, MD=3.25, 95%CI 2.15 to 4.35, Plt;0.000 01), Xuesaitong (two studies, MD=6.12, 95%CI 4.02 to 8.22), Huperzine A (three studies, MD=2.45, 95%CI 1.14 to 3.76, P=0.000 2), and vitamin (two studies, MD=4.00, 95%CI 2.73 to 5.27, Plt;0.000 01). For improving the viability level, donepezil was superior to piracetam (five studies, MD= –3.86, 95%CI –4.83 to –2.89, Plt;0.000 01), Xuesaitong (two studies, MD= –5.49, 95%CI –7.18 to –3.80, Plt;0.000 01), Huperzine A (two studies, MD= –0.78, 95%CI –4.23 to –2.66, P=0.66), vitamin (three studies, MD= –5.88, 95%CI –8.29 to –3.48, Plt;0.000 01), and nimodipine (one study, MD= –7.09, 95%CI –10.81 to –3.37, P=0.000 2). In improving the dementia level (HDS Scale), donepezil was superior to piracetam (one study, MD=5.80, 95%CI 2.78 to 8.82, P=0.000 2), Xuesaitong (one study, MD=3.95, 95%CI 2.32 to 5.58, Plt;0.000 01), vitamin (one study, MD=3.91, 95%CI 0.94 to 6.88, P=0.010), and almitrine (one study, MD=3.37, 95%CI 1.10 to 5.64, P=0.004). Conclusion Current evidence shows that donepezil is likely to be more effective in the treatment of vascular dementia than placebo, piracetam, Xuesaitong, Huperzine A and vitamin. However, for the limited evidence and lower methodological quality of the included studies, this conclusion still needs to be verified with more high-quality RCTs.
目的 采用高效液相色谱-质谱联用法研究盐酸多奈哌齐口腔崩解片的人体药物代谢动力学，并评价其生物等效性。 方法 2009年9月－11月对22例健康男性受试志愿者单次交叉口服盐酸多奈哌齐口腔崩解片（试验制剂）和盐酸多奈哌齐普通片（参比制剂），测定给药后不同时间点血浆中多奈哌齐经时血药浓度，采用DAS 2.0软件进行药物代谢动力学参数计算和生物等效性评价。 结果 受试者单次口服试验制剂与参比制剂后，达峰时间分别为（2.95 ± 1.16）、（3.19 ± 0.98） h，峰浓度分别为（9.98 ± 2.93）、（9.13 ± 2.05） ng/mL，药时曲线下面积（0-t）分别为（470.76± 142.64）、（446.57 ± 137.30）ng/mL·h；药时曲线下面积（0-∞）分别为（517.74 ± 169.79）、（489.47 ± 162.13）ng/mL·h。试验制剂与参比制剂的生物等效性结果为104.7%，其90%置信区间为（98.4%，111.4%）。结论 盐酸多奈哌齐口腔崩解片与普通片生物等效。